The following data is part of a premarket notification filed by Sorin Biomedical, Inc. with the FDA for Dideco Flexible Reservoir -- Product Designation 5063.
| Device ID | K945065 |
| 510k Number | K945065 |
| Device Name: | DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063 |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | SORIN BIOMEDICAL, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92713 -9503 |
| Contact | Ronald S Warren |
| Correspondent | Ronald S Warren SORIN BIOMEDICAL, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92713 -9503 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-14 |
| Decision Date | 1995-05-19 |